Myozyme
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
09-01-2024
Fachinformation
(SPC)
09-01-2024
Öffentlichen Beurteilungsberichts
(PAR)
23-01-2014
Wirkstoff:
alglucosidase alfa
Verfügbar ab:
Sanofi B.V.
ATC-Code:
A16AB07
INN (Internationale Bezeichnung):
alglucosidase alfa
Therapiegruppe:
Other alimentary tract and metabolism products,
Therapiebereich:
Glycogen Storage Disease Type II
Anwendungsgebiete:
Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-α-glucosidase deficiency).In patients with late-onset Pompe disease the evidence of efficacy is limited.
Produktbesonderheiten:
Revision: 25
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2006-03-28
Gebrauchsinformation
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYOZYME 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Alglucosidase alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Myozyme is and what it is used for
2.
What you need to know before you are given Myozyme
3.
How Myozyme is given
4.
Possible side effects
5.
How to store Myozyme
6.
Contents of the pack and other information
1.
WHAT MYOZYME IS AND WHAT IT IS USED FOR
Myozyme is used to treat adults, children and adolescents of all ages
who have a confirmed diagnosis
of Pompe disease.
People with Pompe disease have low levels of an enzyme called
alpha-glucosidase. This enzyme helps
the body control levels of glycogen (a type of carbohydrate). Glycogen
provides the body with energy,
but in Pompe disease the levels of glycogen can get too high.
Myozyme contains an artificial enzyme called alglucosidase alfa –
this can replace the natural enzyme
which is lacking in Pompe disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MYOZYME
DO NOT USE MYOZYME:
If you have experienced life-threatening allergic (hypersensitive)
reactions to alglucosidase alfa or any
of the other ingredients of this medicine (listed in section 6) and
re-administration of the medicine was
not successful. Symptoms of life-threatening allergic reactions
include, but are not limited to, low
blood pressure, very fast heart rate, difficulty breathing, vomiting,
facial swelling, hives or rash.
WARNINGS AND PRECAUTIONS
If you are treated with Myozyme, you may experience an
infusion-associated reaction while you are
being given the medicine or during the hours following the infusion.
Such a re
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Myozyme 50 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 mg of alglucosidase alfa.
After reconstitution, the solution contains 5 mg of alglucosidase
alfa* per ml and after dilution, the
concentration varies from 0.5 mg to 4 mg/ml.
*Human acid α-glucosidase is produced in Chinese hamster ovary cells
(CHO) by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myozyme is indicated for long-term enzyme replacement therapy (ERT) in
patients with a confirmed
diagnosis of Pompe disease (acid
α
-glucosidase deficiency).
Myozyme is indicated in adults and paediatric patients of all ages.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Myozyme treatment should be supervised by a physician experienced in
the management of patients
with Pompe disease or other inherited metabolic or neuromuscular
diseases.
Posology
The recommended dose regimen of alglucosidase alfa is 20 mg/kg of body
weight administered once
every 2 weeks.
Patient response to treatment should be routinely evaluated based on a
comprehensive evaluation of all
clinical manifestations of the disease.
_Paediatric and older people _
There is no evidence for special considerations when Myozyme is
administered to paediatric patients
of all ages or older people.
_ _
_Patients with renal and hepatic impairment_
The safety and efficacy of Myozyme in patients with renal or hepatic
impairment have not been
evaluated and no specific dose regimen can be recommended for these
patients.
3
Method of administration
Myozyme should be administered as an intravenous infusion.
Infusions should be administered incrementally. It is recommended that
the infusion begin at an initial
rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30
minutes if there
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